MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC AGILITY .014 205CM STANDARD; WIRE, GUIDE, CATHETER, NEUROVASCULAR

Model Number	614-481
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Procode: mof/dqx.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (j32p19) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare profession reported that during the procedure, the 0.014in.X 205cm agility 14 standard guidewire (614481 / j32p19) became fractured.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device by the original equipment manufacturer (oem) concert medical.[conclusion]: the healthcare profession reported that during the procedure, the 0.014in.X 205cm agility 14 standard guidewire (614481 / j32p19) became fractured.There was no report of any patient adverse event or complication.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The product was returned and sent to the oem for investigation.The investigational finding is documented below.Investigation summary: the device was examined on the bench and under microscopy.There were two distinct kinks along the length of the wire and one slight kink about 15cm from the distal tip.At the distal region the coil was formed into a tight curl; no kinks and minimal coil stretching was observed.The distal bond and midjoint were both intact.Gentle tension on the tip bond reveals that the corewire is intact.There was no evidence of the guidwire being craked or fractured as reported in the complaint.The reported issue was not confirmed based on the evaluation and analysis performed on the returned device.A review of manufacturing documentation associated with this lot (j32p19) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Conclusion: the damage to the guidewire is not related to the complaint description and may have occurred subsequent to the physician use.The distal tip may have been deformed in a manner that made the device unusable during the procedure.This deformation was likely caused by a combination of factors related to the procedure.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.Updated sections: d.10, g.4, g.7, h.2, h.3, h.6, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(b)(4).The purpose of this mdr is to report that a re-review of the additional event information received on (b)(6) 2020 was performed.The reportability of the file was also reassessed.Based on the information provided, the agility 14 standard guidewire (614481 / j32p19) did not become fractured during the procedure.The device became kinked during the procedure.With this information, the file no longer meets the medical device reporting criteria as a malfunction.No further reports will be forthcoming.

• Brand Name: AGILITY .014 205CM STANDARD
• Common Device Name: WIRE, GUIDE, CATHETER, NEUROVASCULAR
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9583141
• Report Number: 1226348-2020-00001
• Device Sequence Number: 535184
• Product Code: MOF
• UDI-Device Identifier: 10886704029052
• UDI-Public: 10886704029052
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K001033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2019

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: 04/30/2021
• Device Model Number: 614-481
• Device Catalogue Number: 614481
• Device Lot Number: J32P19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 12/21/2019
• Supplement Date Received by Manufacturer: 01/15/2020; 04/28/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 01/21/2020; 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1