MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number 400SMTXSFT0204

Device Problems Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

Please note that the following device code also applies to this complaint: 2578.Results: the pet lock was intact on the proximal end of the penumbra smart coil (smart coil) pusher assembly; the pusher assembly was kinked approximately 134.0 cm from the proximal end; the embolization coil was damaged and intact with the pusher assembly.Conclusions: evaluation of the returned device revealed that the smart coil pusher assembly was kinked.This type of damage likely occurred due to improper handling during use.If the device is forcefully advanced against resistance, damage such as this may occur.Further evaluation revealed that the embolization coil to the smart coil was damaged.This type of damage likely occurred due to forceful manipulation against resistance.The incompatible microcatheter that was used with the smart coil likely contributed to the friction that was encountered when attempting to advance the smart coil.The non-penumbra devices mentioned in the complaint was not returned for evaluation.Smart coils are 100% functionally tested during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil through another manufacturer's microcatheter, the physician encountered friction.The physician made another attempt to advance the coil through the microcatheter and still met the same friction.After further examination, the hospital staff realized that they were using a microcatheter for a pipeline device rather than one for the smart coil.Therefore, the microcatheter was removed and a compatible microcatheter from another manufacturer was opened.The physician wanted to use a new smart coil to continue the procedure as the first one may have been forced or compromised.The procedure was successfully completed using a new smart coil and the new microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5780725
• MDR Text Key: 49128009
• Report Number: 3005168196-2016-00952
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015286
• UDI-Public: 00814548015286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2016

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
• Device Operator: Physician
• Device Expiration Date: 11/09/2020
• Device Catalogue Number: 400SMTXSFT0204
• Device Lot Number: F66442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1