MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G26119
Medical Device Problem Codes	Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = unknown.Investigation - evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufactures instructions and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states to ¿flush the catheter lumen labeled "distal" using heparinized saline solution.Apply negative pressure to lumen labeled "balloon" prior to introduction.Advance the balloon dilation catheter counter-clockwise over a pre-positioned.014 inch (0.36 mm) wire guide.Activate the hydrophilic coating by wiping the balloon with heparinized saline solution.Under fluoroscopy, advance the balloon to the lesion site.Carefully position the balloon across the lesion using both the distal ad proximal radiopaque balloon markers.Note: if resistance is met while advancing the balloon dilation catheter, determine the cause and proceed with caution." based on the information provided and no product returned, investigation has concluded that a cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
As reported, during a renal angiogram involving a (b)(6) patient with renal stenosis, an advance micro ¿ 14 ultra low-profile pta balloon catheter elongated and separated.The device was reported to be flushed with 20 milliliters of saline and another manufacturer's 0.014 inch guide wire was "wiped down".An unknown manufacturer's sheath was utilized during the case.The physician attempted to advance the complaint device over the wire and noted resistance upon advancement.The physician then decided to remove the device over the wire.During removal of the balloon from the wire, the device "tore".Elongation/stretching was noted prior to the device separating into "3 or 4 pieces".The device did not enter the patient's body.No further intervention was required once the balloon was removed from the wire.The device was disposed of by the customer and the procedure was completed successfully with another device of the same type.As reported, the physician "stated that she felt that she might not have hydrated it enough".A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8557887
• Report Number: 1820334-2019-00885
• Device Sequence Number: 14030540
• Product Code: LIT
• UDI-Device Identifier: 10827002261195
• UDI-Public: (01)10827002261195(17)200821(10)8157008
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K122940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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: 08/21/2020
• Device Model Number: G26119
• Device Catalogue Number: PTA3-14-90-2-2
• Device Lot Number: 8157008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 MO