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Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Event Date 01/30/2004
Event Type  Injury  
Manufacturer Narrative
Suspect medical device: 4-french coaxial micropuncture set. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Event Description
The below report of a 4- french coaxial micropuncture set used during a procedure in which a 12-fr drainage catheter perforated the patient's descending aorta was taken from the following article: hatfield, m. Et. Al. , "angio-seal device used for hemostasis in the descending aorta. American journal of roentgenology 183. 3 (2004): 612-614. "an (b)(6) year-old woman was admitted from a nursing home with a chief complaint of shortness of breath. The family requested minimal palliative care. The portable chest radiograph (fig. 1a) obtained at admission showed an atelectatic left lower lobe with a moderate left effusion, hyperinflation of the right lung, and cardiomegaly. Ct was not ordered before the procedure, and the patient had no further preprocedural workup. The patient was referred to the radiology department for placement of a percutaneous chest tube for decompression of the left effusion and reexpansion of the left lung. Sonographic guidance without color-flow doppler sonography was used. Conscious sedation was provided. With the patient in the right decubitus position, a cook 4- french coaxial micropuncture set (cook) was placed in what was thought to be the small effusion via a left posterolateral puncture. Care was taken to avoid the enlarged left ventricle. The tract was serially dilated, and a 12-french cook multipurpose drainage catheter (cook) was placed to function as a chest tube. Its tip was positioned overlying the posterior left chest cavity. A specimen was not obtained because diagnostic fluid was not requested. The chest tube was connected to [a competitor] water seal chest drain [manufacturer]. Rapid filling of the collection chamber with sanguineous or serosanguineous material was noted, and the patient became tachycardic and hypotensive. The chest tube was immediately clamped, and iv fluids were administered aggressively. A hand injection of contrast material into the chest catheter showed the chest tube to be within the thoracic arch of the aorta. (fig. 1b). The vital signs quickly stabilized. A total of approximately 800 ml of blood was drained. The patient¿s blood was typed and crossmatched, and she was subsequently transfused with 2 u. The thoracic surgery service, the patient¿s family, and her primary physician were consulted. After discussing various treatment options and recognizing the patient¿s poor surgical risk, we decided that the best treatment was to attempt placement of one or two 8-french angio-seal vascular closure devices at the aortic puncture site. This off-label use and other treatment options were discussed with the patient¿s family. A sheath was placed via a right common femoral arterial puncture with its tip in the descending aorta. A deflated 27-mm occlusion balloon was positioned just above the thoracic puncture site to control any future potential arterial hemorrhage and for additional angiographic injections of contrast material. The drainage catheter was removed and replaced with a 9- french 25-cm long [product name] vascular sheath [manufacturer] with its tip in the thoracic arch. A 9-french sheath was selected because its outer diameter is roughly 11 to 12 french. Two guidewires were then placed, and the sheath was removed. First, a single 8-french angio-seal vascular closure device was deployed in the standard fashion. Trace amounts of hemorrhage were noted on follow-up angiography performed by injecting contrast material through the balloon occlusion catheter (fig. 1c). A second 8-french angio-seal vascular closure device was deployed. Again, minimal continued hemorrhage was observed on aortography (fig. 1d). Gentle percutaneous traction on the two device strings was applied for 10 min. Follow-up angiography showed no evidence of hemorrhage (fig. 1e). The sutures were then taped taut to the skin with skin closure strips [manufacturer]. The following day, the sutures were cut flush with the skin. After we were confident that the hemorrhage had been controlled, a second 12-french catheter was then placed with its tip in the mid chest cavity using a lateral approach and sonographic guidance. Approximately 140 ml of clear yellow fluid was removed from the left pleural space, and no significant hemorrhage was identified. The patient recovered completely. Over the next few days, the chest tube drained a small amount of yellow fluid and no blood. Chest ct performed 5 days later showed no sign of hemorrhage (fig. 1f). Unfortunately, the chest tube was unsuccessful in reexpanding the left lung, which progressively collapsed. The patient died 10 days later. The underlying cause of the atelectatic left lung was unknown. " the 12-french multipurpose drainage catheter is captured in the medwatch report with patient identifier (b)(6). The 4- french coaxial micropuncture set is captured in the medwatch report with patient identifier (b)(6).
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
MDR Report Key12500828
MDR Text Key272485863
Report Number1820334-2021-02183
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2021 Patient Sequence Number: 1