MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN

Model Number	1001782J-HC
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The 3.0x15mm xience xpedition referenced was filed under a separated medwatch report#.Evaluation summary: visual inspection was performed.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 other than the ones reported from this incident.The investigation was unable to determine a conclusive cause of the separations since there was no information available.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Reportedly, the affiliate was inspecting return products at the local warehouse when they noticed a 3.0x38mm xience xpedition stent delivery system (sds), a 3.0x15mm xience xpedition sds, and two 014 bmw hydro guide wire outside their carton.The pouches were opened and re-closed with a stapler.The 3.0x15mm xience xpedition sds had notes on the label stating: stent broken inside the catheter.No other information was provided for the other devices.No additional information was provided.Return device analysis on one of the.014 bmw hydro guide wires observed that the shaping ribbon was separated and the tip coils were stretched out and separated.The separated pieces were not returned.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6690728
• Report Number: 2024168-2017-05669
• Device Sequence Number: 771707
• Product Code: DQX
• UDI-Device Identifier: 08717648026010
• UDI-Public: (01)08717648026010(17)161231(10)5011671
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K013833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2017

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: 12/30/2016
• Device Model Number: 1001782J-HC
• Device Catalogue Number: 1001782JS-HC
• Device Lot Number: 5011671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR