MAUDE Adverse Event Report: COOK INC RETRACTA DETACHABLE EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number N/A

Device Problems Stretched (1601); Unraveled Material (1664); Difficult or Delayed Separation (4044)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: equipment officer.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required placement of a retracta detachable embolization coil for an unknown procedure.When the operator retracted the coil in order to change its position, the delivery wire unraveled.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Correction: this report is being sent to indicate the complaint event is not reportable.Upon further investigation, this event is not reportable.There is no information confirming device malfunction or serious injury.The user indicated the patient experienced negligible harm as a result of this event.A review of risk documentation does not indicate that this event is likely to cause serious injury if it were to reoccur.As there are no recorded incidences of serious injury due to the complaint event, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is considered not reportable.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: RETRACTA DETACHABLE EMBOLIZATION COIL
• Type of Device: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10268005
• MDR Text Key: 198733427
• Report Number: 1820334-2020-01296
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002341972
• UDI-Public: (01)10827002341972(17)211005(10)7282894
• Combination Product (y/n): N
• PMA/PMN Number: K151676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2021
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-14-6
• Device Lot Number: 7282894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1