MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
After the physician did a successful angioplasty, he began removing the balloon from the patient's body.As he was removing the balloon, he felt some resistance.After he removed it from the patient, he noticed that the balloon looked shorter.He quickly looked under fluro.And notice the distal portion of the balloon completely separated from the delivery catheter.It was on the wire and located at the distal part of the sheath.The physician tried everything to remove the piece of the balloon without removing the wire, but nothing would advance through the sheath with the wire in place.He ended up removing the hydro st wire and the part of the balloon migrated down to the distal popliteal.He quickly advanced a goose neck snare and retrieved the part of the balloon.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the device history record, drawings, manufacturing instructions, specifications, and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirms the balloon separated from the shaft of the catheter.The shaft shows signs of elongation around the separation site.The catheter shaft measured 161.2cm in length.The advance 14lp device has completed design control requirements showing the device meets the predetermined requirements and that the requirements meet the needs of the user.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
After the physician did a successful angioplasty, he began removing the balloon from the patient¿s body.As he was removing the balloon, he felt some resistance.After he removed it from the patient, he noticed that the balloon looked shorter.He quickly looked under fluro.And notice the distal portion of the balloon completely separated from the delivery catheter.It was on the wire and located at the distal part of the sheath.The physician tried everything to remove the piece of the balloon without removing the wire, but nothing would advance through the sheath with the wire in place.He ended up removing the hydro st wire and the part of the balloon migrated down to the distal popliteal.He quickly advanced a goose neck snare and retrieved the part of the balloon.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5742046
• Report Number: 1820334-2016-00517
• Device Sequence Number: 18834208
• Product Code: LJT
• UDI-Device Identifier: 10827002503219
• UDI-Public: (01)10827002503219(17)190121(10)6540157
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2016

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: PTAX4-14-170-2.5-4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/02/2016
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2016
• Supplement Report FDA Received Date: 12/07/2016
• 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
• Patient Age: 61 YR