MAUDE Adverse Event Report: COOK INC CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age at time of event was not provided.Patient sex at time of event was not provided.(b)(4).This event is currently under investigation.
Event or Problem Description
During an angioplasty for at artery procedure, the physician accessed from the dp artery.Did not use an introducer sheath but had the bare uniglide wire and crossed cto retrograde.The patient had an occlusion in the at artery up to the papatile.The uniglide was locked in and cxi catheter across the occlusion.The physician wanted to exchange the catheter and while removing felt no resistance.When the catheter was removed it was noted that approximately 15cm of the catheter had separated and remained in the patient.The physician attempted to retrieve with a snare but was unsuccessful.Due to the occlusion and the difficulty of removal the physician left the fragment.No further procedures are planned and the patient was doing well and released to go home.Additional information provided by the rep states: after removing the catheter from the patient, the physician cut off a portion (distal 5 cm) of the catheter with scissors thinking that he would put it into the patient again with a clean cut.He ultimately did not put the catheter back into the patient.The piece that broke off during the procedure remained inside the patient's body.It was the physician's decision to leave the catheter fragment inside the patient.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history, quality control, device history record, instructions for use (ifu), documentation and a visual inspection of the returned product was conducted.Two fragments of a used device were returned for investigation.The proximal portion of the device measured 70.8 cm in length.The mid-section of the device showed discoloration and elongation of 4mm and measures 4.4cm in length.The distal portion of the device was not returned for investigation.A review of the device history record showed no nonconforming events which could contribute to this failure mode.Design verification testing has been performed to ensure the catheter force at break meets the iso 10555-1 requirement of 10 n.There is no evidence to suggest the product was not made to specifications.The device is shipped with an instruction for use (ifu) that describes the intended use contraindications, warnings and precautions, and the correct procedures.The ifu indicates that ¿the catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ based on visual inspection of the returned product it is feasible to suggest that the device encountered forces beyond its design.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
During an angioplasty for at artery procedure, the physician accessed from the dp artery.Did not use an introducer sheath but had the bare uniglide wire and crossed cto retrograde.The patient had an occlusion in the at artery up to the papatile.The uniglide was locked in and cxi catheter across the occlusion.The physician wanted to exchange the catheter and while removing felt no resistance.When the catheter was removed it was noted that approximately 15cm of the catheter had separated and remained in the patient.The physician attempted to retrieve with a snare but was unsuccessful.Due to the occlusion and the difficulty of removal the physician left the fragment.No further procedures are planned and the patient was doing well and released to go home.Additional information provided by the rep states: after removing the catheter from the patient, the physician cut off a portion (distal 5 cm) of the catheter with scissors thinking that he would put it into the patient again with a clean cut.He ultimately did not put the catheter back into the patient.The piece that broke off during the procedure remained inside the patient's body.It was the physician's decision to leave the catheter fragment inside the patient.

• Brand Name: CXI SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5630139
• Report Number: 1820334-2016-00280
• Device Sequence Number: 18832599
• Product Code: KRA
• UDI-Device Identifier: 00827002525467
• UDI-Public: (01)00827002525467(17)190311(10)6805869
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2016

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 Model Number: N/A
• Device Catalogue Number: CXI-4.0-35-90-P-NS-0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2016
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2016
• Supplement Report FDA Received Date: 10/11/2016
• 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: Required Intervention