MAUDE Adverse Event Report: ABBOTT VASCULAR 014 HI-TORQUE PILOT; GUIDE WIRE

Model Number	1010480-HJ
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.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 similar incidents reported from this lot for irregular texture.A conclusive cause for the reported irregular texture or too much lubricity cannot be determined.The reported patient effect of perforation is listed in the guide wire hi-torque instructions for use ce fda as a known patient effect of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the pilot guide wire was advanced without difficulty to the calcified and tortuous lesion in the left circumflex coronary artery in the patient with an acute myocardial infarction.The physician commented that the guide wire was very lubricious and it was necessary to hold it.Multiple balloons were used to predilate the lesion, but a stent was unable to reach the lesion due to the vessel calcification.The procedure was completed with balloon angioplasty only, but a vessel perforation occurred.It is suspected that the pilot guide wire is related to the perforation.No treatment was required for the perforation.The patient is in stable condition.There was no adverse patient sequelae.No additional information was provided.
Event or Problem Description
It was reported that the pilot guide wire was advanced without difficulty to the calcified and tortuous lesion in the left circumflex coronary artery in the patient with an acute myocardial infarction.The physician commented that the guide wire was very lubricious and it was necessary to hold it.Multiple balloons were used to predilate the lesion, but a stent was unable to reach the lesion due to the vessel calcification.The procedure was completed with balloon angioplasty only, but a vessel perforation occurred.It is suspected that the pilot guide wire is related to the perforation.No treatment was required for the perforation.The patient is in stable condition.There was no adverse patient sequelae.No additional information was provided.
Additional Manufacturer Narrative
There was no reported device malfunction and the product was not returned.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 similar incidents reported from this lot for irregular texture.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.A conclusive cause for the reported irregular texture or too much lubricity cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The g4 date on the initial mdr was incorrectly reported as 03/05/2020; however, the correct date is 03/06/2020.

• Brand Name: 014 HI-TORQUE PILOT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9884068
• Report Number: 2024168-2020-02944
• Device Sequence Number: 11448342
• Product Code: DQX
• UDI-Device Identifier: 08717648073861
• UDI-Public: 08717648073861
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 05/31/2021
• Device Model Number: 1010480-HJ
• Device Catalogue Number: 1010480-HJ
• Device Lot Number: 9061171
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Weight: 70