MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SEEKER CROSSING SUPPORT CATHETER; CATHETER, PERCUTANEOUS

Model Number	SK6535M
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that upon removal of the support catheter from the device packaging, approximately 5cm of the tip of the catheter was allegedly detached.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Visual inspection: a partial support catheter and storage hoop were returned with the product packaging and label.No kinks were noted to the catheter.No anomalies were noted to the hub.7.8cm of distal tip was missing and not returned.The remaining catheter measures 57.2cm from strain relief to distal end.Functional/performance evaluation: functional testing of the device was not performed.Medical records review: medical records were not provided for review.Image/photo review: one photo was provided and reviewed.The photo shows a support catheter coiled in the inner sleeve packaging.The distal tip appears to be missing.Based on the photo the investigation is confirmed for break.Conclusion: the device and one photo were returned.The investigation was confirmed for break as the tip was noticed missing from the package and not returned.All seeker catheters are inspected 100% for cosmetic and functional defects.Therefore, it is unlikely the tip break is manufacturing related.It is unknown whether handling techniques by the user as they removed the catheter from the packaging or prepped the device may have contributed to the tip detachment.Based upon the available information a definitive root cause has not been determined.Labeling review: the current ifu (instructions for use) states: warnings: contents supplied sterile using ethylene oxide (eo).Non-pyrogenic.Do not use if sterile barrier is opened or damaged.Single patient use only.Do not reuse, reprocess or resterilize.Precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Do not continue to use the seeker® crossing support catheter if the shaft has been damaged or kinked.(b)(4).
Event or Problem Description
It was reported that upon removal of the support catheter from the device packaging, approximately 5cm of the tip of the catheter was allegedly detached.There was no patient contact.

• Brand Name: SEEKER CROSSING SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6577265
• Report Number: 2020394-2017-00475
• Device Sequence Number: 905675
• Product Code: DQY
• UDI-Device Identifier: 00801741067938
• UDI-Public: (01)00801741067938(17)181007(10)VTAX0165
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K103367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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: 10/07/2018
• Device Model Number: SK6535M
• Device Catalogue Number: SK6535M
• Device Lot Number: VTAX0165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1