MAUDE Adverse Event Report: ABBOTT VASCULAR INDEFLATOR PPAK PLUS 30; ACCESSORIES

Model Number	1000183
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
The procedure was performed to treat a lesion in the ostium of the left anterior descending artery and the left main artery.The handle of the plus 30 indeflator broke inside the chamber while attempting to deflate an unspecified balloon catheter.A syringe was used to deflate the balloon.The procedure was successfully completed with a new indeflator.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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.Broken devices can be a result of, but not limited to, manufacturing, mishandling, or external force applied to the device (tapping indeflator to clear air bubbles, strong twisting during inflation/deflation).It is possible that inadvertent mishandling and/or an excessive amount of force was applied to the device while attempting to deflate resulting in the reported break; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: INDEFLATOR PPAK PLUS 30
• Common Device Name: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10603163
• Report Number: 2024168-2020-08108
• Device Sequence Number: 17098551
• Product Code: MAV
• UDI-Device Identifier: 08717648013584
• UDI-Public: 08717648013584
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K962495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 04/30/2021
• Device Model Number: 1000183
• Device Catalogue Number: 1000183
• Device Lot Number: 60242630
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR