MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 3MMX10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDF10031030
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(fremont).The device lot number is not available / not reported.The expiration date of the device is not known.Initial reporter information such as the name, phone and email address are not available / unknown.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.The device manufacture date is not known as the device lot number is not available / not reported.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure of an aneurysm, the 3 mm x 10 cm deltapaq 10 cerecyte coil (cdf10031030 / lot#: unknown) the physician was repositioning the coil in aneurysm and was attempting to resheath the coil when it became stretched.The resheathing attempt was made when the coil was partially deployed; it was confirmed that the coil was not used as a guidewire.It was confirmed that continuous flush had been maintained in the sl-10® microcatheter (stryker).There was no resistance between the guidewire and the microcatheter, no resistance at any time during the advancement of the coil through the microcatheter.Prior to the reported issue with the deltapaq 10 cerecyte coil, other coils (quantity not known) were advanced through the same microcatheter.The entire coil was safely removed undetached.There was no flow restriction or reduction associated with the event; no clinically significant procedural delay.The procedure was successfully completed without complications.There was no report of patient injury or adverse event.It was reported that the product is available to be returned for evaluation.
Additional Manufacturer Narrative
Manufacturer¿s ref.(b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the coil embolization procedure of an aneurysm, the 3 mm x 10 cm deltapaq 10 cerecyte coil (cdf10031030 / lot#: unknown) the physician was repositioning the coil in aneurysm and was attempting to resheath the coil when it became stretched.The resheathing attempt was made when the coil was partially deployed; it was confirmed that the coil was not used as a guidewire.It was confirmed that continuous flush had been maintained in the sl-10® microcatheter (stryker).There was no resistance between the guidewire and the microcatheter, no resistance at any time during the advancement of the coil through the microcatheter.Prior to the reported issue with the deltapaq 10 cerecyte coil, other coils (quantity not known) were advanced through the same microcatheter.The entire coil was safely removed undetached.There was no flow restriction or reduction associated with the event; no clinically significant procedural delay.The procedure was successfully completed without complications.There was no report of patient injury or adverse event.The product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 3 mm x 10 cm deltapaq 10 cerecyte coil was received contained in a pouch.The device underwent visual inspection.The hub was observed without any damage.The device positioning unit (dpu) was kinked at 49 cm from the proximal end.The coil introducer was zipped and in good condition.The resheathing tool was without any damage observed on it.Microscopic inspection was performed.The v-notch was in good condition.The resistance heating (rh) and articulation joint were both in good condition; both were outside of the coil introducer.The rh showed no evidence that it had been heated.The embolic coil was outside of the coil introducer and was observed to be stretched.Functional testing was precluded by the condition of the returned device; the dpu was kinked and the embolic coil was stretched.The device lot number was not available.The device history record (dhr) review could not be performed without the lot number.The reported issue that the 3 mm x 10 cm deltapaq 10 cerecyte coil became stretched was confirmed during the microscopic inspection of the returned device; the embolic coil was found to be in stretched condition.Coil stretching is a known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue from occurring.The complaint documented that the physician was repositioning the coil and was attempting to resheath it when it became stretched; the stretched coil condition was confirmed when the device was returned and underwent microscopic observation.It is possible that during the resheathing attempt, inadvertent force was exerted and as a result, the coil became stretched.The exact cause of the stretch cannot be conclusively determined.The lot number of the device is not known, therefore review of the device history record was not performed; without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 3 mm x 10 cm deltapaq 10 cerecyte coil left the manufacturing facility with the coil in the observed stretched condition.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to make a correction to the manufacture information in sections d and g, and to report that the product was received by cerenovus product analysis lab on (b)(6) 2019.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: DELTAPAQ CERE 3MMX10CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CA CH-24 00; SZ CH-2400
• MDR Report Key: 8470948
• Report Number: 3008114965-2019-00963
• Device Sequence Number: 16792879
• Product Code: HCG
• UDI-Device Identifier: 00878528007210
• UDI-Public: 00878528007210
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K080437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2019

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 Catalogue Number: CDF10031030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 05/06/2019; 06/06/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/06/2019; 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1