MAUDE Adverse Event Report: ABBOTT VASCULAR COPILOT; ACCESSORIES

Catalog Number 1003330

Device Problems Difficult to Insert (1316); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The device was not returned for analysis.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 from this lot.The investigation determined the reported difficulties appears to be related to circumstances of the procedure as it is likely that the cap seal was not entirely opened; thus resulting in the reported difficulty to insert and the reported irregular appearance (inlet of y-valve was narrow).The reported delayed therapy/non-surgical treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the patient presented with a myocardial infarction and the procedure was performed to treat a lesion in the left anterior descending coronary artery with moderate calcification.An unspecified guide wire was inserted through a copilot bleed back control valve without issue.On attempting to advance an unspecified balloon catheter through the copilot, resistance was met and the inlet of the copilot was noted to be narrow.A new copilot bleed back control valve was used to successfully continue the procedure; however, the event prolonged the operation time and radiation exposure to the patient.The final patient outcome was reported to be satisfactory.No additional information was provided.

• Brand Name: COPILOT
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR,REG #2024168; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8942550
• MDR Text Key: 156015177
• Report Number: 2024168-2019-11309
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013980
• UDI-Public: 08717648013980
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1003330
• Device Lot Number: 60172094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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 Outcome(s): Other