MAUDE Adverse Event Report: STERILMED, INC.; CATHETER, ELECTRODE RECORDING

Catalog Number	R10439011
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to an atrial fibrillation procedure with a reprocessed soundstar eco 8f diagnostic ultrasound catheter, damages to the packaging of the catheter were noticed.When the catheter was removed from the box, a big hole was discovered on the pouch of the packaging.There was no visible damage to the catheter and the catheter was not removed from the packaging.It is unknown how or when the damages to the packaging occurred.The damage compromised the sterility of the device.
Additional Manufacturer Narrative
The product analysis lab received the device for evaluation.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.In addition, two photos were received.The first photo shows the inner label of a reprocessed soundstar eco 8f diagnostic ultrasound catheter.The second photo shows the inner pouch of the device, and a punctured condition was noted at the strain relief level.No other damages can be observed, as the rest of the inner pouch was not shown in the photo.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The issue reported regarding the packaging of the reprocessed catheter being damaged was confirmed based on the photos provided.This investigation was performed based only on the photos provided.Since the product has been returned, an assessment will be performed as per the conditions of the device returned.As part of sterilmed's quality process all devices are manufactured, inspected, and released to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 sterilmed inc., or its employees that the report constitutes an admission that the product, sterilmed inc., 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.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that prior to an atrial fibrillation procedure with a reprocessed soundstar eco 8f diagnostic ultrasound catheter, damages to the packaging of the catheter were noticed.When the catheter was removed from the box, a big hole was discovered on the pouch of the packaging.The device was returned to sterilmed for further evaluation.A non-sterile reprocessed soundstar eco 8f diagnostic ultrasound catheter was received contained in the decontamination bag.Upon receiving the device, visual inspection was performed, and only the catheter was returned.Neither the inner pouch nor the outer packaging was returned for analysis.No damages were noted on the catheter.The physical mark on the catheter indicated it had been reprocessed one (1) time.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The issue reported regarding a damaged pouch cannot be evaluated since the component was not returned for evaluation.As part of sterilmed's 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.Additionally, without the original packaging a root cause of this finding cannot be assigned.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: NA
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20446731
• Report Number: 2134070-2024-00020
• Device Sequence Number: 15476548
• Product Code: OWQ
• UDI-Device Identifier: 10888551045087
• UDI-Public: (01)10888551045087(17)250617(10)2215792
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 06/17/2025
• Device Catalogue Number: R10439011
• Device Lot Number: 2215792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown