MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II; WIRE, GUIDE, CATHETER

Model Number	1009666J
Medical Device Problem Codes	Stretched (1601); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a 75% stenosed lesion in the anterior descending artery.The ht bmw universal ii guide wire (gw) was used in the procedure; however, the coils of the gw became exposed [polymer coating split/torn] and a vessel dissection occurred.It is unknown if the dissection was treated.Final patient outcome was timi ii flow.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
Subsequent to initial report being filed additional information was received stating that the reported coils became "exposed" meant the coils of the guide wire were stretched.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported stretched coils.The reported patient effect of dissection is listed in the hi-torque guide wires instruction for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B5 - describe event or problem: updated.D9, h3 - the device was initially reported as returning for analysis but the device was not returned.H6 - medical device problem code 4008 was removed.
Additional Manufacturer Narrative
A visual inspection was performed don the returned device.The reported stretched coils were confirmed.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported stretched coils.Additionally, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.It was reported that during use the coils were observed to be stretched.Factors that may contribute to stretched coils include, but are not limited to, interaction with challenging anatomy, interaction with accessory devices, manipulation against resistance, or user technique.In this case, there was no damage or anomalies noted to the guide wire during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.It is possible that circumstances of the procedure, such as interaction with the anatomy, contributed to the reported stretched coils.The reported patient effect(s) of dissection is listed in the hi-torque guide wires instruction for use as a known patient effect(s) of coronary stenting procedures.There is no indication of a product quality issue; therefore, no product related corrective action is required.D1 correction: brand name updated, d2a correction: common device name updated, d3 correction: name, address updated, d9 correction device available for evaluation updated to yes.
Event or Problem Description
It was reported that the procedure was to treat a 75% stenosed lesion in the anterior descending artery.The ht bmw universal ii guide wire (gw) was used in the procedure; however, the coils of the gw became exposed [polymer coating split/torn] and a vessel dissection occurred.It is unknown if the dissection was treated.Final patient outcome was timi ii flow.Subsequent to initial report being filed additional information was received stating that the reported coils became "exposed" meant the coils of the guide wire were stretched.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 17541635
• Report Number: 2024168-2023-08739
• Device Sequence Number: 6712872
• Product Code: DQX
• UDI-Device Identifier: 08717648118777
• UDI-Public: (01)08717648118777(17)240731(10)2082771
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K152709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 1009666J
• Device Catalogue Number: 1009666J
• Device Lot Number: 2082771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 10/18/2023; 07/12/2024
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 10/24/2023; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female