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

Catalog Number B1120-040

Device Problems Detachment Of Device Component (1104); Material Rupture (1546); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2014

Event Type  malfunction  

Event Description

It was reported that the armada was prepared according to the device instructions for use.It was advanced to the shuntogram in the non-calcified brachial artery.The resistance encountered during advancement to the lesion was not out of the ordinary.During the first inflation, using an inflation device, there was an audible pop between nominal and rated burst pressure.Although the physician appreciates that balloon ruptures occur, he was concerned in this case because the tip separated from the balloon as seen on fluoroscopy.The armada was removed from the anatomy, followed by the tip when the guidewire was removed.There were no pieces of the device left in the patient.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional, relevant information.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported balloon rupture and separation were confirmed.The reported resistance and noise heard during rupture could not be confirmed as they were based on circumstances of the procedure.Based on a visual inspection and sem (scanning electron microscopy) analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other incidents for balloon rupture, separation, resistance, or noise reported from this lot.Based on the reviewed information, no product deficiency was identified.Evaluation summary: the reported balloon rupture and separation were confirmed.The reported resistance and noise heard during rupture could not be confirmed as they were based on circumstances of the procedure.Based on a visual inspection and sem (scanning electron microscopy) analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other incidents for balloon rupture, separation, resistance, or noise from this lot.Based on the reviewed information, no product deficiency was identified.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3996428
• MDR Text Key: 4954263
• Report Number: 2024168-2014-05069
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: B1120-040
• Device Lot Number: 40403G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 109