MAUDE Adverse Event Report: ABBOTT VASCULAR HT PILOT; GUIDE WIRE

Catalog Number	1010481-HJ
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Codes	Arrhythmia (1721); Foreign Body In Patient (2687)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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.Na.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified unspecified coronary artery.A 300 cm pilot 150 guide wire was used without any issues.However, after removing the device from the anatomy, it was noted that the polymer coating from the distal area seems to have been peeled off and detached.No additional information was provided.
Event or Problem Description
Subsequent to the initial report, additional information was received.The device met initial resistance with the anatomy.Although it was reported that no polymer particles were left inside the artery, there may have been foreign material left inside the anatomy.The patient also developed arrhythmia during the procedure, however there is no information regarding treatment.Dilatation of the circumflex was not performed due to inability to cross the lesion with a non-abbott balloon.The procedure was stopped to not exceed the contrast media and rx dose.The device was received for evaluation.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported detachment was unable to be confirmed; however, there was a noted polymer scratching likely due to manipulation during retraction.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.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.The investigation determined the reported separation, polymer peeling and difficulty to advance/position appear to be related to circumstances of the procedure.Based on the reported information, during advancement through the moderately calcified anatomy, the guide wire encountered resistance and likely became damaged and trapped.Manipulation during retraction likely resulted in the reported separation and peeling.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 manufacture, design or labeling.

• Brand Name: HT PILOT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8823601
• Report Number: 2024168-2019-10321
• Device Sequence Number: 343693
• Product Code: DQX
• UDI-Device Identifier: 08717648073885
• UDI-Public: 08717648073885
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/20/2019

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: 02/28/2021
• Device Catalogue Number: 1010481-HJ
• Device Lot Number: 9032271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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; Disability