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

Model Number	1000186
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The indeflator was connected with a stopcock.And the device lock did not close properly.It was noted to have a leak since it could not inflate the balloon.Another indeflator was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
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 incidents from this lot.It is possible that the indeflator and stopcock were not properly aligned and/or not fully connected/tightened resulting in the reported loose connection and the reported leak; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Additionally, the device lock did not close properly and the indeflator was used on the balloon.It should be noted the indeflator 20/30 instructions for use states: do not use if the product is damaged.The deviations to the instructions for use do not appear to have caused/contributed to the reported leak or loose connection.It is possible that the indeflator and stopcock were not properly aligned and/or not fully connected/tightened resulting in the reported loose connection and the reported leak; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.H6: medical device problem code 2983 removed; 1371 added.
Additional Manufacturer Narrative
The device was returned for analysis.The reported leak was unable to be replicated in a testing environment due to the condition of the returned device.The reported loose/intermittent connection was able to be confirmed as resistance was met when turning the indeflator into the lock position of the returned device.It is possible that inadvertent mishandling during unpackaging and/or during preparation for use resulted in compromising/damaging the device; thus resulting in the reported difficulties (leak, loose connection)/noted damages (faceplate gap, lock position resistance); however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10, h3 - it was initially reported that the device would not be returning for analysis.Subsequent information revealed that the device was returned for evaluation.H6: component code: 3083, 839 added.H6: type of investigation code: 4114 removed; 10 added.H6: investigation findings code: 213 removed.H6: investigation conclusions code 67, 18 removed; 4315 added.

• Brand Name: 20/30 PRIORITY PACK ACCESSORY KIT
• Common Device Name: 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: 15925669
• Report Number: 2024168-2022-12273
• Device Sequence Number: 15051083
• Product Code: MAV
• UDI-Device Identifier: 08717648013614
• UDI-Public: 08717648013614
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K961471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2023

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: 06/30/2024
• Device Model Number: 1000186
• Device Catalogue Number: 1000186
• Device Lot Number: 60384380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 02/02/2023; 04/06/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 02/06/2023; 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown