MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS, LLC COOK MOTION HYBRID WIRE GUIDE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	MHW-035150
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing and inspection records did not identify any contributing factors to the failure reported.All inspection results were recorded within the specification limits.The device was received for evaluation.Based on the evidence demonstrating conformance of the manufacturing process to all applicable specifications, coupled with the significant damage to the guidewire from the clinical procedure, this complaint appears to be the result of substantial use conditions rather than a design or processing issue at heraeus.Review of the device history record showed all production and sterilization processes met specification.It appears the tip of the guidewire became entrapped in some manner and as it was retracted, it was damaged to a point at which the tip was sheared off and the coil was stretched.If additional information is received, a supplemental report will be filed.
Event or Problem Description
On (b)(6) 2019, (b)(6) community hospital informed (b)(4) (distributor of device) of an event involving a motion hybrid wire guide of unknown lot number.During a cystoscopy and stent placement procedure, "wire went past the impacted stone but the tip of the wire sheared off.The tip is inside patient; the tip of the wire will be removed in a week at the same time the stent is removed." a cystoscopy with stent removal was later performed to remove the separated tip.

• Brand Name: COOK MOTION HYBRID WIRE GUIDE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS, LLC; 2605 fernbrook lane north; suite j; plymouth MN 55447
• MDR Report Key: 8813380
• Report Number: 2315342-2019-00003
• Device Sequence Number: 2470851
• Product Code: EZB
• UDI-Device Identifier: 00827002448469
• UDI-Public: (01)00827002448469(17)220210(10)PL06139
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2022
• Device Model Number: MHW-035150
• Device Lot Number: PL06139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/22/2019
• 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: Hospitalization; Required Intervention