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

Catalog Number	1013470-100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned.Visual and functional inspections were performed on the device.The reported difficulty was confirmed.Additionally, the balloon was noted to be ruptured.It may be possible that the balloon folds and profile dimensions became compromised after the first inflation and removal.The rupture likely occurred due to the outer surface of the balloon becoming damaged during the attempt to reinsert.Based on the information reviewed and analysis of the returned device, a conclusive cause for the reported difficulty could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.
Event or Problem Description
It was reported the procedure was to treat a lesion in the heavily calcified, heavily tortuous left superficial femoral artery.The 7.0mm x 100mm x135 cm armada 35 balloon dilatation catheter (bdc) was successfully used for pre-dilatation; however, the bdc was not able to re-advance through the non-abbott 5x6fr introducer sheath for post dilatation of an unspecified stent.The armada bdc was removed from the sheath without issue.A 6.0mm x 80mm armada 18 bdc was successfully used for post dilatation.It was noted that a larger balloon was needed and a 6.0mm x 100mm x150 cm armada 18 bdc was successfully used for pre-dilatation, however the bdc was not able to re-advance through the non-abbott introducer sheath; the bdc was removed from the sheath without issue.A 6.0mm x 80mm armada 18 bdc was used without issue to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis revealed the balloon was ruptured.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: 7225871
• Report Number: 2024168-2018-00659
• Device Sequence Number: 1229301
• Product Code: LIT
• UDI-Device Identifier: 08717648208423
• UDI-Public: 08717648208423
• 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): 01/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 1013470-100
• Device Lot Number: 7092741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 118