MAUDE Adverse Event Report: COOK INC AMPLATZ RENAL DILATOR SET; KOE DILATOR, URETHRAL

Catalog Number	075000
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that prior to performing a procedure, the operator observed a hair-like fiber inside of the sealed package containing an amplatz renal dilator set.This issue was discovered prior to use and the device was not used.The device did not come in contact with a patient.Not used on patient; no patient involvement and no patient impact.
Additional Manufacturer Narrative
Investigation/evaluation: the investigation performed for this complaint report included a review of complaint history, the device history record, and specifications.No issues were identified that are related to the reported complaint.A visual inspection of the returned device was also conducted during the investigation.One unopen package labeled rpn 075000, label lot 5754303 was received.Visual observation of the package confirmed a hair inside the sealed package.Based on the evidence presented by the sample and the physical analysis, this event has been contributed to a manufacturing event.The device history record was reviewed and found no related non-conformances noted during the manufacturing process.A review of complaint history revealed this is the only reported complaint associated to complaint lot number 5754303.Based on all of the above information, it is reasonable to suggest the foreign matter was introduced at some point during the manufacturing or packaging processes.The root cause is manufacturing related.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.

• Brand Name: AMPLATZ RENAL DILATOR SET
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6803144
• Report Number: 1820334-2017-02529
• Device Sequence Number: 11140133
• Product Code: KOE
• UDI-Device Identifier: 00827002142923
• UDI-Public: (01)00827002142923(17)180326(10)5754303
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K811833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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: No Information
• Device Catalogue Number: 075000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1