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

Catalog Number 400SMTHXSFT1H04

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 135.0 and 136.5 cm from the proximal end.The embolization coil was intact with its pusher assembly.The introducer sheath was removed by the penumbra investigator and the inner diameter (id) was measured and found to be within specification.The outer diameter (od) of the mid-joint was measured and found to be within specification.Conclusions: evaluation of the returned device revealed resistance when advancing when advancing the pusher within the sheath.Further evaluation of the returned device revealed that the pusher assembly was kinked.If the device is forcefully advanced against resistance, damage such as this may occur.During the functional test resistance was encountered as the pusher assembly mid-joint was advanced through the introducer sheath.The pusher assembly kinks prevented the introducer sheath from being retracted off the pusher assembly during the functional test.The introducer sheath was removed by the penumbra investigator and the inner diameter (id) was measured and found to be within specification.The outer diameter (od) of the mid-joint was measured and found to be within specification.The root cause of the reported failure could not be determined.The non-penumbra microcatheter referred to in the complaint was not returned to penumbra for evaluation.Penumbra coils are visually 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 using penumbra smart coils (smart coils).During the procedure, the physician successfully placed three smart coils using a non-penumbra microcatheter.The physician then attempted to advance another smart coil out of its introducer sheath and into a bowl of saline, however the physician felt resistance, and the pusher assembly became kinked.The procedure was therefore completed using a new smart coil.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7476469
• MDR Text Key: 107017989
• Report Number: 3005168196-2018-00888
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015675
• UDI-Public: 00814548015675
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2018

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: 10/18/2022
• Device Catalogue Number: 400SMTHXSFT1H04
• Device Lot Number: F80062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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
• Patient Age: 71 YR