MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Catalog Number	CAT8XTORQ115
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 8 (cat8).During the procedure, the physician noticed that the tip of the cat8 was kinked.Therefore, the procedure was completed using a new cat8.
Additional Manufacturer Narrative
Results: the returned device was kinked at approximately 104.0 cm and 109.0 cm from the hub.The device was ovalized at approximately 17.0 cm, 24.0 cm, 101.0 cm, 102.0 cm, 108.0 cm and 112.0 cm from the hub.During functional testing, a 0.088¿ mandrel was inserted into the returned cat8 and the mandrel was able to advance through the cat8 with some resistance due to the kinks and ovalizations on its length.Conclusions: evaluation of the returned cat8 confirmed a kink on its distal shaft.If the device is forcefully retracted at extreme angles from its packaging or otherwise mishandled during preparation, damage such as a kink may occur.Further investigation revealed an additional kink and ovalizations along the length of the returned cat8.These damages were likely incidental and may have occurred during packaging for returned to penumbra.Penumbra catheters 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.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8545375
• Report Number: 3005168196-2019-00781
• Device Sequence Number: 361293
• Product Code: DXE
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2018
• Report Date (Section F): 01/01/2005

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: 06/10/2021
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: F83946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 05/02/2019; 06/14/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/31/2019; 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Date Report Sent to FDA: 01/01/2005