MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B1100-040
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Evaluation summary: a visual and functional inspection was performed on the returned device.The reported balloon rupture, balloon separation and difficult to remove from the introducer sheath were confirmed.The reported inflation issue was unable to be confirmed due to the condition of the device.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 similar incidents reported from this lot.The armada 35 global, instructions for use (ifu) states that the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries.The ifu violation does not appear to have contributed to the reported detachment of the device, inflation issue, difficulty to remove or material rupture.The investigation determined the reported difficulties of irregular inflation, balloon rupture and difficulty removing the device from the sheath, caused the balloon separation and resulted in the subsequent cut down procedure to remove the balloon fragment from the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during a procedure of the eccentric, moderately calcified, restenosed, shunt in the lower arm area, a non-abbott guide wire and 6 fr non-abbott sheath were positioned.The 10-x40x80 mm armada 35 balloon dilatation catheter (bdc) was advanced to the lesion and inflated to under rated burst pressure (rbp).At some point, the balloon inflated in a dumb-bell-like shape.During the third inflation, the balloon ruptured.The lesion was fully expanded.As the bdc was being removed, resistance was met and the bdc caught in the distal part of the sheath.The bdc was forcefully pulled and the device separated.The proximal shaft and half of the balloon were removed.The distal fragment remained in the anatomy.Surgical cutdown was used to remove the balloon fragment.The procedure was prolonged, but there was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 35 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: 7508182
• Report Number: 2024168-2018-03504
• Device Sequence Number: 13877254
• Product Code: LIT
• UDI-Device Identifier: 08717648154942
• UDI-Public: 08717648154942
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: B1100-040
• Device Lot Number: 70922G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/11/2018
• 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: MEDIKIT SUPERSHEATH 6F
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 70