MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CEREBASE; CATHETER, PERCUTANEOUS

Catalog Number	GS9080SD
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.The complaint was submitted with a photograph of the device, which is pending further analysis.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, prior to use, a cerebase gs 90, 80 cm, straight, distal catheter (gs9080sd, 31294722) was found broken in the packaging with no sign of damage to the packaging.There was no patient injury as the device was not clinically used.There was no procedural delay due to the event.
Additional Manufacturer Narrative
Manufacturer ref#:(b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h6 and h11.One photo accompanied the complaint file and shows the proximal portion of the vestamid with a cracked condition.The catheter shaft is still connected by the internal braid; the vestamid was noted not fully separated.The rest of the device is not observed in the photo and no further damages could be noted.A manufacturing record evaluation was performed for the finished device 31294722 number, and no non-conformances related to the malfunction were identified.As part of the j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.The reported issue was confirmed based on the cracked condition observed on the vestamid.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3 and h11.Complaint conclusion: as reported by the field, prior to use, a cerebase gs 90, 80 cm, straight, distal catheter (gs9080sd, 31294722) was found broken in the packaging with no sign of damage to the packaging.There was no patient injury as the device was not clinically used.There was no procedural delay due to the event.One photo accompanied the complaint file and shows the proximal portion of the vestamid with a cracked condition.The catheter shaft is still connected by the internal braid; the vestamid was noted not fully separated.The rest of the device is not observed in the photo and no further damages could be noted.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances related to the malfunction were identified.The reported issue was confirmed based on the cracked condition observed on the vestamid.This investigation was performed based only on the photo provided.As part of the j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.The instructions for use (ifu) contain the following caution: ¿ carefully inspect all devices prior to use.Verify size, length, and condition are suitable for the specific procedure.Do not use a cerebase da guide sheath, dilator, or hemostasis valve that has been damaged in any way; replace with another guide sheath, dilator, or hemostasis valve.A damaged device may cause complications.Exercise care in handling the cerebase da guide sheath to reduce the chance of accidental damage.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h11.A non-sterile gs 90, 80 cm, straight, distal was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the device was found to be fractured just next to the id band.No other damages were found.The fracture was inspected under a microscope and it was observed that the internal braid wire was exposed.Elongation marks were noted on both edges.The other joints in the distal region of the catheter were intact, without obvious separations.The fracture surfaces of the vestamid shaft show stretching and tearing of the shaft material at the edges of the fracture, indicating material elongation and tearing.The issue regarding a catheter being broken was confirmed based on the fractured condition found on the catheter.The catheter was received with a fracture of the vestamid shaft.This is a known failure mode of the catheter and can occur on a properly fused catheter.The observed condition could be the result of several factors, including but not limited to procedural factors present in the operating room such as operator¿s technique.According to the risk documentation, a catheter being damaged is a potential issue that can occur due to an inappropriate handling catheter during the device removal from the package.The instructions for use (ifu) include precaution to inspect the guide sheath upon removal from packaging to verify that it is undamaged.A conclusive cause cannot be determined since the device was returned without the original package.A manufacturing record evaluation was performed for the finished device 31294722 number, and no internal actions related to the malfunction were identified.As part of j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no internal action activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following caution: ¿ carefully inspect all devices prior to use.Verify size, length, and condition are suitable for the specific procedure.Do not use a cerebase da guide sheath, dilator, or hemostasis valve that has been damaged in any way; replace with another guide sheath, dilator, or hemostasis valve.A damaged device may cause complications.Exercise care in handling the cerebase da guide sheath to reduce the chance of accidental damage.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: CEREBASE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21514325
• Report Number: 3008114965-2025-00172
• Device Sequence Number: 20838155
• Product Code: QJP
• UDI-Device Identifier: 10886704082316
• UDI-Public: (01)10886704082316(17)260531(10)31294722
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K192806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: GS9080SD
• Device Lot Number: 31294722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 04/21/2025; 04/29/2025; 10/23/2025; 11/14/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/22/2025; 04/29/2025; 10/24/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown