MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WHISPER ES GUIDE WIRE

Model Number	1011834HJ
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the account distributor quality representative, received a hi-torque whisper extra support guide wire (gw), with a cut in the inner pouch, compromising the sterility of the device.The guide wire was not used in a patient.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned pouch and dispenser coil and the reported tear on the pouch was confirmed.Additionally, it was noted that there was a visible scratch on the outer ring of the coil dispenser.The scratch on that outer ring of the coil dispenser lined up consistently to that of the tear on the pouch.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 and/or complaints reported from this lot.Factors that may contribute to packaging component damage may include but are not limited to mishandling during manufacturing/addendum labeling, damage during shipment, mishandling during receiving/storage at the account, and/or mishandling during unpackaging at the account.To help ensure this damage does not occur during the manufacturing/relabeling process, all stent delivery systems are 100% visually inspected for damage at numerous points in the manufacturing process, including at the point that the product is inserted into the dispenser coil.Based on the reported information, scanning electron microscopy (sem) and returned analysis, the investigation was unable to determine a conclusive cause for the reported packaging tear damage, and scratch/nick on the dispenser coil.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the initial filed report, the following information was received: reportedly, the chipboard box was opened by removing the adhesive tape that sealed it and no tools were used.The logistic intern noticed the damage to the inner packaging; however, the outer chipboard box had no damage.

• Brand Name: HI-TORQUE WHISPER ES GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12544354
• Report Number: 2024168-2021-08710
• Device Sequence Number: 17436740
• Product Code: DQX
• UDI-Device Identifier: 08717648116094
• UDI-Public: 08717648116094
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101116
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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: 11/30/2022
• Device Model Number: 1011834HJ
• Device Catalogue Number: 1011834HJ
• Device Lot Number: 0121071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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