MAUDE Adverse Event Report: PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER; DQY

Catalog Number PXSLIMSTR

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2019-01513, 3005168196-2019-01514, 3005168196-2019-01515, 3005168196-2019-01516, 3005168196-2019-01517, 3005168196-2019-01518, 3005168196-2019-01519, 3005168196-2019-01520.

Event Description

The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using a px slim delivery microcatheter (px slim), a neuron max 6f 088 long sheath (neuron max), a benchmark 6f 071 delivery catheter (benchmark), and penumbra smart coils (smart coils).It should be noted that there was a tortuous tonsillar loop in the common carotid artery (cca).During the procedure, the physician advanced the neuron max into the patient¿s anatomy but felt that it would not provide enough support to guide the px slim over the tonsillar loop.Therefore, the neuron max was removed and was no longer used in the procedure.The physician then decided to use a benchmark as the guide.However, while advancing the benchmark halfway through the tonsillar loop, it was reported that the benchmark felt stiff.The physician decided not to advance the benchmark any further into the patient¿s anatomy and it was therefore removed from the procedure.A non-penumbra sheath was then advanced, followed by the same px slim; however, the px slim was not compatible with the technique the physician preferred to use and was therefore removed from the procedure.There was no other issue noted with the px slim.A non-penumbra microcatheter was then successfully advanced through the sheath and into the target location and several smart coils and other coils were implanted into the aneurysm.It was also reported that the physician experienced a "coarse" and "grainy" feeling while advancing a 5x15 smart coil through the microcatheter.Additionally, the 5x15 smart coil was only able to advance approximately 60% of the way out of the microcatheter.The 5x15 smart coil was therefore retracted and removed from the procedure.While attempting to advance another smart coil, the physician noted that it was only able to advance approximately 1 cm from its initial position within its introducer sheath.This smart coil was subsequently removed and was not used in the procedure.The same issue also occurred with four additional smart coils; these smart coils were also removed and were not used in the procedure.The procedure was completed successfully using forty coils.There was no report of an adverse effect to the patient.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Type of Device: DQY
• 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: 8858101
• MDR Text Key: 153355463
• Report Number: 3005168196-2019-01512
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016436
• UDI-Public: 00814548016436
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K100826
• 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: 01/01/2005,05/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2020
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F73551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1