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

Catalog Number 400SMTHXSFT0102

Device Problems Physical Resistance (2578); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra smart coil's (smart coil) embolization coil was intact with the pusher and had offset coil winds near the proximal end.Conclusions: evaluation of the returned device revealed the embolization coil had offset coil winds near the proximal end.This type of damage typically occurs if the introducer sheath is not properly aligned in the hub of the microcatheter prior to advancement.The offset coil winds caused resistance while advancing during functional testing.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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 in the anterior communicating artery (a-com) using penumbra smart coils (smart coils).During the procedure, the physician placed six smart coils and three non-penumbra coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil out of its introducer sheath and into the microcatheter, the physician experienced resistance and the coil became stuck at the hub of the microcatheter; therefore, it was removed.The procedure was completed using two other smart coils and the same 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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7289332
• MDR Text Key: 100919276
• Report Number: 3005168196-2018-00387
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 00814548015613
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2018

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: 04/16/2022
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F75680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• 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