MAUDE Adverse Event Report: ABBOTT VASCULAR 20/30 PRIORITY PACK ACCESSORY KIT; ACCESSORIES

Catalog Number 1000186

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that the indeflator could not deflate the balloon catheter as it was blocked [the indeflator syringe did not make any movement]; therefore, a syringe was used to deflate the balloon.There was no adverse patient effects reported and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.

• Brand Name: 20/30 PRIORITY PACK ACCESSORY KIT
• 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 road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18936944
• MDR Text Key: 338084393
• Report Number: 2024168-2024-03516
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013614
• UDI-Public: 08717648013614
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K961471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/19/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1000186
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic