MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013469-060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).Evaluation summary: visual inspections were performed on the returned device.A longitudinal balloon rupture was identified.Additional information received confirmed that the physician was not aware of the balloon rupture.The reported difficult to position was unable to be confirmed due to the noted rupture damage.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lesion in the non-tortuous superficial femoral artery.After positioning a 5/6fr non-abbott sheath in the anatomy, a 5.5mm x 60mm x 150cm otw armada 18 balloon dilatation catheter (bdc) was advanced via right posterior tibial access and pre-dilatation was performed without issue.The bdc was withdrawn without difficulty and an unspecified stent was deployed.When attempting to re-advance the bdc through the same sheath for post-dilatation of the stent, resistance was felt against the sheath and the bdc was unable to be advanced through the sheath.The bdc was retracted without resistance.A new 5.5mm x 80mm x 150cm armada 18 was advanced through the same sheath without difficulty and post-dilatation was successfully completed.There were no adverse patient effects and no occurrence of a clinically significant delay.The 5.5mm x 60mm x 150cm otw armada 18 bdc was received with a longitudinal balloon rupture.Additional information received confirmed that the physician was not aware of the balloon rupture.No additional information was provided.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6564919
• Report Number: 2024168-2017-04125
• Device Sequence Number: 815544
• Product Code: LIT
• UDI-Device Identifier: 08717648208294
• UDI-Public: (01)08717648208294(17)200229(10)6091241
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2017

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: 02/29/2020
• Device Catalogue Number: 1013469-060
• Device Lot Number: 6091241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 5/6FR TERUMO GLIDESHEATH
• Patient Age: 79 YR
• Patient Weight: 68