MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER-14 DUAL MARKER

Catalog Number	606151X
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(4).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01084 & 1226348-2019-00943.
Event or Problem Description
As reported by a healthcare professional, during a cerebral embolization to the left anterior communicating artery, a 2.5 mm x 3.3 cm micrusframe 10 coil (mfr100253, l14834), did not advance through the prowler 14 microcatheter (mc) during delivery.The user removed both the coil and the microcatheter and used new prowler and coil.After the change of the devices, the user was able to continue with the embolization with no problem.There was no patient injury reported.There was a 20 minutes procedural delay due to the event.After inspection of the microcatheter, it looks like the distal portion was kinked.No evidence of when if happened and if it is the cause of this situation.The devices were visually inspected for damage prior to use.The devices were used and prepped as per the instructions for use.Adequate flush been maintained through the devices.The devices did not kink or bend at any time prior to the resistance/friction.No excessive force been applied to the devices.The rhv is not a problem, it wasn´t too tight.
Additional Manufacturer Narrative
Product complaint (b)(4).This is one of four products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01084, 3008114965-2019-01171 and 1226348-2019-00982.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, during a cerebral embolization to the left anterior communicating artery, a 2.5mm x 3.3cm micrusframe10 coil (mfr100253, l14834), did not advance through the prowler 14 microcatheter (mc) during delivery.The user removed both the coil and the microcatheter and used new prowler and coil.After the change of the devices, the user was able to continue with the embolization with no problem.There was no patient injury reported.There was a 20 minutes procedural delay due to the event.After inspection of the microcatheter, it looks like the distal portion was kinked.No evidence of when it happened and if it is the cause of this situation.The devices were visually inspected for damage prior to use.The devices were used and prepped as per the instructions for use.Adequate flush been maintained through the devices.The devices did not kink or bend at any time prior to the resistance/friction.No excessive force been applied to the devices.The rhv is not a problem, it wasn´t too tight.Additional information received indicated that a second micrusframe10 coil (unknown product code/lot) did not advance through a second prowler-14 dual marker microcatheter (606151x, 30051292) during delivery.A non-sterile prowler-14 dual marker microcatheter was received inside of a pouch.The hub was inspected, and it was found in good normal condition.The body was inspected, and it was found compressed and kinked in multiple sections.The distal tip was inspected, and it was found compress and kinked.The functional test could not be performed due the conditions of the received device (body- kinked/compressed).A manufacturing record evaluation was performed for the finished device 30051292 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿catheter (body/shaft - obstructed with mc loss of cerebral target position¿ was confirmed due to that during the visual inspection some compressed/kinked sections was noted on the body of the device.The complaint reported by the customer ¿brite tip/distal tip- kinked/bent¿ was confirmed during the visual inspection some compressed/kinked sections was noted on the distal tip.However, the cause of compress condition found on the device was apparently caused by applying excessive force on the device, but it could not be conclusively determined.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.Based on the information provided; it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: PROWLER-14 DUAL MARKER
• Common Device Name: PROWLER
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8773243
• Report Number: 1226348-2019-00943
• Device Sequence Number: 2038989
• Product Code: KRA
• UDI-Device Identifier: 10886704028628
• UDI-Public: 10886704028628
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K972518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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 Expiration Date: 03/31/2021
• Device Catalogue Number: 606151X
• Device Lot Number: 30051292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICRUSFRAME10 2.5MM X 3.3CM; PROWLER-14 DUAL MARKER; UNKMICRUSFRAME